Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome
Stopped early · Phase 2
Conditions studied: Myelodysplastic Syndrome (MDS)
In brief
Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS).
Key facts
- Study ID
- NCT01422486
- Run by
- Telik
- People needed
- 2
- Starts
- 2011-10-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2013-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Primary or de Novo MDS
- Low or Intermediate-1 IPSS risk MDS
- Deletion of the 5q chromosome [del(5q) MDS]
- Refractory or resistant to lenalidomide (Revlimid)
- ECOG performance score of 0 or 1
- Documentation of significant anemia with or without additional cytopenia
- Adequate kidney and liver function
- Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry
You may not qualify if…
- Prior allogenic bone marrow transplant for MDS
- Known sensitivity to ezatiostat (injection or oral tablets)
- Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)
- History of MDS IPSS risk score of greater than 1.0
- Pregnant or lactating women
- Any severe concurrent disease, infection or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
- Oral steroids greater than 10 mg per day. Exceptions: those prescribed for other conditions (such as new adrenal failure, asthma, arthritis) or brief steroid use (such as tapered dosing for an acute non-MDS condition)
- History of hepatitis B or C, or HIV
Where it is running
- Loyola University — Maywood, Illinois, United States
- SIU School of Medicine, Simmons Cancer Center — Springfield, Illinois, United States
- Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
- Columbia University — New York, New York, United States
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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